Clinical evaluation refers to collecting, appraisal, and analysis of clinical data on a medical device and evaluating whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and efficacy when using the device according to the manufacturer’s instructions for use. The clinical evaluation report is a common element of the technical documentation of a medical device required by many regulatory bodies worldwide. In EU market, clinical evaluation is conducted as an ongoing process throughout the lifecycle of a medical device. It is initially performed during the development of a medical device to gain market access and must be actively updated after that.
Comparison Between Chinese CER and EU CER Requirements
Guidance to be compliant with
“Technical Guidance on Clinical Evaluation of Medical Devices” issued by NMPA
MEDDEV 2.7/1 Rev. 4 MDR 2017/745
Periodical update
Not required under Order #680
Required
Evaluation Approach
• Only equivalence route is allowed under Order #680
• Equivalence route • Clinical evaluation solely based on the subject device’s clinical evidence
Equivalent Device
• Must be approved in China • Using a competitor’s device as an equivalent device is challenging but still feasible if equivalence can be demonstrated • Must be equivalent in all 16 recommended comparison aspects
• Must be CE-marked (exceptions will be considered) • Using a competitor’s device as an equivalent device is impossible • Must be equivalent in clinical, technical, and biological aspects
State of the art
Not required
Required
China literature review
Required
Not required
Appraisal
Limited to literature appraisal, e.g., level of evidence according to the Oxford Evidence Based Medicine
The following aspects of pertinent data shall be appraised: • Methodological quality and the scientific validity • Relevance to the clinical evaluation • Weighting the contribution of each data set to the overall clinical evaluation
CER format
A recommended format is included in the guidance (Annex 1 – Annex 8).
A suggested format for the clinical evaluation report is located at Appendix A9 of the MEDDEV 2.7/1 rev 4
